Design nonclinical drug development programs for a variety of drug classes.
Provide support for all phases of nonclinical drug development activities including toxicology, pharmacokinetics, ADME, and safety pharmacology programs.
Establish and manage all interactions with contract research organizations (CROs) including:
Prepare nonclinical sections of:
INDs, NDAs, etc., in Common Technical Document (CTD) format for regulatory filings (e.g., FDA, EMA, Health Canada).
Interact with regulatory agencies.
Qualify impurities in drug substances and drug products.
Provide assistance with government contracts (experience as PI).
Provide product liability/forensic toxicology support.Having a big sale, on-site celebrity, or other event? Be sure to announce it so everybody knows and gets excited about it.
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